Development and preliminary validation of a clinician-administered Chinese-language tool for breakthrough cancer pain...

To develop a brief, clinician-administered Chinese-language Breakthrough Cancer Pain Assessment (BCPA) instrument and evaluate its content validity, inter-rater reliability, and ability to detect change in selected rescue medication-related items.

The 11-item BCPA was developed from literature review, clinical input, and three Delphi rounds with 14 experts. Inter-rater reliability was evaluated through independent physician and nurse interviews with 30 participants with cancer and breakthrough cancer pain (BTcP). In an exploratory observational phase, selected BCPA responses were compared in 77 participants before and 7 days after routine-care initiation of fentanyl buccal soluble film.

In the third Delphi round, all items had an item-level content validity index of 1.00 and the scale-level content validity index based on universal agreement (S-CVI/UA) was 1.00. Kappa coefficients for categorical items ranged from 0.507 to 0.888, and intraclass correlation coefficient [ICC(2,1)] values for numerical items ranged from 0.836 to 0.979. The proportion reporting pain relief within 15 minutes increased from 33.8% to 66.2% (matched-pairs odds ratio, 4.57; 95% CI, 2.02-10.35; P < 0.001). Mean satisfaction with the effectiveness of rescue medication increased from 5.96 to 7.60, and perceived improvement in sleep and mood increased from 6.01 to 7.40 (both P < 0.001).

The Chinese-language BCPA showed preliminary content validity and inter-rater reliability. Selected rescue medication-related items detected pre/post changes in an uncontrolled observational sample. Further evaluation of response processes, criterion-related validity, cross-cultural validity, and responsiveness is required before routine clinical implementation.